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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PATELLA 35MM PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PATELLA 35MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091); Rupture (2208)
Event Date 01/18/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products - persona natural cemented stemmed tibial component size e left catalog #: 42532007101 lot #: 63189523, persona ultracongruent fixed bearing articular surface 11mm left catalog #: 42512200511 lot #: 62335084, persona trabecular metal curciate retaining narrow porous femoral component catalog #: 42502206201 lot #: 63199066. It was indicated by the complainant that the device would not be returned to zimmer biomet for investigation, as the device remains implanted. The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records. The device history records were reviewed and no discrepancies relevant to the reported event were identified. Review of the primary operative noted that the patient was suffering from severe left knee osteoarthritis. No intraoperative complications were noted and the knee was noted to have excellent stability throughout range of motion while maintaining full motion. Review of operative report from the patient's retinacular repair noted that there was no evidence of infection and that the components were intact. There was a small retinacular rent that was repaired with vicryl and the knee tracked nicely through range of motion. Per package insert for the persona knee system, pain and swelling are some of the known adverse effects of total knee arthroplasty. However, a definitive root cause cannot be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. This report was previously submitted erroneously on apr 6, 2018 and may 22, 2018 under manufacturing report number 0001822565-2018-02057.

 
Event Description

It is reported that the patient underwent a left knee retinaculum repair three months post-operatively due to pain, swelling, redness, a hematoma and retinacular rupture. During the procedure, all components were found to be intact.

 
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Brand NamePERSONA ALL POLY PATELLA 35MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7751452
MDR Text Key116053108
Report Number0002648920-2018-00554
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540000035
Device LOT Number63432243
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/05/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/06/2018 Patient Sequence Number: 1
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